FDA Related News

Marketing

Sen. Durbin Calls for Crackdown on DTC Telehealth

Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platforms due to concerns ab...

Human Drugs

ICH Guide on Including Pregnant Women in Trials

FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.

Human Drugs

FDA Rejects Genentechs Bid to Expand Columvi Use

FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.

Human Drugs

Panel Votes Down Rexulti for PTSD

FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when used in combination wi...

FDA AI Moves Raise Questions: Attorneys

Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial intelligence tool and ap...

Human Drugs

Panel Votes Down GSK Multiple Myeloma Drug

FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults with multiple myeloma ...

Human Drugs

Dexcom Recalls Dexcom Glucose Monitor Receivers

Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert from sounding.

Investigate GLP-1 Online Marketing: Blackburn

Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigation into what they sa...

CDER Losing Staff In Droves: Report

An online post details a significant number of resignations from CDER in the first six months of this year.

Human Drugs

Alert on B.Braun Microbore Extension Sets

FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed from the market becau...